NCT06095349

Brief Summary

The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

4.2 years

First QC Date

October 10, 2023

Last Update Submit

January 18, 2024

Conditions

Hydrogen SulfideOsteoporosis

Outcome Measures

Primary Outcomes (3)

  • Measurement of biomarkers of bone turnover, marker #1

    Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation

    15 days

  • Measurement of biomarkers of bone turnover, marker #2

    Bone-specific alkaline phosphatase (BAP), marker of bone formation

    15 days

  • Measurement of biomarkers of bone turnover, marker #3

    serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption

    15 days

Secondary Outcomes (1)

  • Measurement of serum H2S levels

    15 days

Study Arms (1)

Bone turnover markers

EXPERIMENTAL

Concentrations of bone turnover markers will be assessed before and after treatment. Correlation will be sought for with H2S levels and clinical features of the patients

Other: inhalatory treatment with sulfureous aerosol

Interventions

inhalatory treatment with sulfureous aerosolOTHER

osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol

Bone turnover markers

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost-menopausal women, a condition which is associated with the development of osteoporosis
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • post-menopausal women with a diagnosis of osteopenia

You may not qualify if:

  • concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

October 1, 2019

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

IT(1)